A Study to Investigate the Efficacy and Safety of Apraglutide Compared With Placebo in Adult Participants With Short Bowel Syndrome Associated With Intestinal Failure (SBS-IF)
Start Date
8/1/2026
Completion Date
10/1/2029
Summary
This Phase 3 placebo-controlled study is planned to further investigate the efficacy, safety, and tolerability of apraglutide in the overall SBS-IF (short bowel syndrome associated with intestinal failure) population during 24 weeks of study treatment. It is expected that approximately 124 participants will be randomized worldwide to either apraglutide or placebo in a 1:1 ratio in this trial.
Detailed Description
This is a multicenter, double-blind, randomized, placebo-controlled, parallel-group, Phase 3 study to investigate the efficacy, safety, and tolerability of apraglutide compared with placebo in adults with SBS-IF. The study population will be representative of the SBS-IF general population and will include adult participants (≥18 years of age) who are dependent on, and who are receiving, PS at least 3 days per week. Eligible participants will be randomized 1:1 to receive SC apraglutide or placebo once weekly for 24 weeks stratified by anatomy (i.e., colon-in-continuity \[CIC\] or stoma) and baseline parenteral support (PS) volume (i.e., \<12 L/week or ≥12 L/week). The number of randomized participants in CIC and stoma will be monitored to ensure approximately equal numbers of CIC and stoma participants are randomized. The study will consist of 4 periods: a Screening Period prior to randomization (including optimization and stabilization phases), a Treatment Period starting at randomization, a Safety Follow-up (SFU) Period after the last dose of IMP is completed, and an Anti-Drug Antibody (ADA) Follow-up Period beginning after the last dose of IMP. All participants who complete the IMP treatment will be offered participation in an open label single arm apraglutide long-term extension (LTE) study. Participants who do not wish to continue onto the LTE study will be requested to complete an SFU Visit, which will occur 4 weeks (±1 week) after the last dose of IMP, after which they will transition into ADA Follow-Up period.
Eligibility Criteria
Age Range: 18 years to No maximum
Interventions
Apraglutide
Placebo
Conditions
Locations
Ronald Reagan UCLA Medical Center, Center for the Health Sciences
Los Angeles, California 90095
United States
Denver Health Medical Center
Denver, Colorado 80204
United States
MedStar Georgetown University Hospital
Washington D.C., District of Columbia 20007
United States
University of Florida Health (UF Health)
Gainesville, Florida 32610
United States
GI Pros
Naples, Florida 34102
United States
Cleveland Clinic Florida
Weston, Florida 33331
United States
Loyola University Medical Center
Maywood, Illinois 60153
United States
UofL Physicians - Colon & Rectal Surgery
Louisville, Kentucky 40202
United States
Henry Ford Medical Center - Columbus
Novi, Michigan 48377
United States
Albany Medical Center
Albany, New York 12208
United States
Mount Sinai Medical Center, RMTI - Intestinal Transplantation & Rehabilitation
New York, New York 10029
United States
Duke University Medical Center
Durham, North Carolina 27710
United States
Gastro Health - Clifton
Cincinnati, Ohio 45219
United States
Cleveland Clinic - Cleveland
Cleveland, Ohio 44195
United States
OSU Wexner Medical Center
Columbus, Ohio 43210
United States
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania 19104
United States
Vanderbilt University Medical Center
Nashville, Tennessee 37232
United States
Buenos Aires Italian Hospital
Buenos Aires, C1199ABB
Argentina
Allende Sanatorium
Córdoba, X5000JHQ
Argentina
San Martin General La Plata Acute General Regional Hospital
La Plata, B1904CFU
Argentina
CDC Medical Center
Luján, M5505
Argentina
St Vincent's Hospital (Melbourne) Ltd
Fitzroy, VIC 3065
Australia
Austin Hospital
Heidelberg, VIC 3084
Australia
Royal Brisbane and Women's Hospital, Gastroenterology and Hepatology
Herston, QLD 4029
Australia
Fiona Stanley Hospital, Harry Perkins Medical Research Institute
Perth, WA 6150
Australia
Order Hospital Linz Ltd. - Hospital of Sisters of Mercy, Department of Surgery
Linz, Upper Austria 4010
Austria
University Hospital Graz
Graz, 8010
Austria
University Hospital Antwerp (UZA), Department of Gastroenterology and Hepatology
Edegem, 2650
Belgium
University Hospitals Leuven, Campus Gasthuisberg, Department of Gastroenterology
Leuven, 3000
Belgium
Hospital Sao Marcos
Teresina, Piauí 64001-280
Brazil
Caxias Do Sul University / Clinical Research For Multicenter Studies Institute
Caxias do Sul, Rio Grande do Sul 95070-560
Brazil
Porto Alegre Clinical Hospital (HCPA)
Porto Alegre, Rio Grande do Sul 90035-903
Brazil
Pontifical University Of Rio Grande Do Sul (PUCRS) - St. Luke Hospital
Porto Alegre, Rio Grande do Sul 90610-000
Brazil
Regional Medical School Foundation (CIP HB/FAMERP)
São José do Rio Preto, São Paulo 15090-000
Brazil
QualiVida Higienopolis - Hapvida NotreDame
São Paulo, São Paulo 01233-000
Brazil
University of São Paulo Faculty of Medicine Clinics Hospital
São Paulo, São Paulo 05403-000
Brazil
Pacific Gastroenterology Associates
Vancouver, British Columbia V6Z 2K5
Canada
CHUM - University of Montreal Hospital Centre
Montreal, Quebec H2X 3E4
Canada
University Hospital Brno, Clinic of Internal Medicine - Gastroenterology
Brno, 625 00
Czechia
University Hospital Hradec Kralove, 3rd Internal Clinic of Geronto-Metabolic
Hradec Králové, 500 05
Czechia
University Hospital Kralovske Vinohrady, Internal Clinic
Prague, 100 00
Czechia
General University Hospital in Prague
Prague, 128 08
Czechia
Rigshospitalet - University Hospital Copenhagen
Copenhagen, DK-2100
Denmark
Beaujon Hospital - APHP
Clichy, 92110
France
Hospices Civils de Lyon - Lyon Sud
Lyon, 69310
France
Nantes University Hospital Center - Hotel Dieu Hospital
Nantes, 44000
France
Bordeaux University Hospital Center - Haut-Leveque Hospital, Haut-Leveque Hospital
Pessac, 33600
France
Nancy Regional University Hospital Center - Brabois Hospital
Vandœuvre-lès-Nancy, 54500
France
University Hospital Heidelberg, Department of Endocrinology and Metabolism
Heidelberg, Baden-Wurttemberg 69120
Germany
University Hospital Erlangen
Erlangen, Bavaria 91054
Germany
Asklepios Clinic St. Georg
Hamburg, Free and Hanseatic City of Hamburg 20099
Germany
University Hospital Bonn
Bonn, North Rhine-Westphalia 53127
Germany
University Duisburg-Essen, University Hospital Essen
Essen, North Rhine-Westphalia 45147
Germany
University Hospital Muenster
Münster, North Rhine-Westphalia 48149
Germany
University Hospital Aachen AoeR
Aachen, Rhine-Westphalia 52074
Germany
Charite - University Hospital Berlin
Berlin, State of Berlin 10117
Germany
Semmelweis University, Department of Surgery, Transplantation and Gastroenterology
Budapest, H-1082
Hungary
University of Szeged, Department of Internal Medicine- Western Site
Szeged, H-6725
Hungary
Rambam Health Care Campus, Institute of Gastroenterology, Nutrition Clinic
Haifa, 3109601
Israel
Shaare Zedek Medical Center, Digestive Diseases Institute, Nutrition Clinic
Jerusalem, 9103102
Israel
Meir Medical Center, Institute of Gastroenterology and Liver Diseases
Kfar Saba, 4428164
Israel
The Tel Aviv Sourasky Medical Center, Institute of Gastrointestinal and Liver Diseases, Nutrition Clinic
Tel Aviv, 64239
Israel
Chaim Sheba Medical Center, Institute of Gastrointestinal Diseases, Nutrition Unit
Tel Litwinsky, 5262000
Israel
Polyclinic San Matteo, IRCCS
Pavia, Lombardy 27100
Italy
University Hospital of Padova
Padova, Veneto 35128
Italy
IRCCS University Hospital of Bologna, Polyclinic S. Orsola-Malpighi
Bologna, 40138
Italy
Careggi University Hospital
Florence, 50134
Italy
Maggiore Polyclinic Hospital, Foundation IRCCS Ca' Granda
Milan, 20122
Italy
University Hospital City of Health and Science of Turin - Hospital Molinette
Torino, 10126
Italy
Yokohama Municipal Citizen's Hospital
Yokohama, Kanagawa 221-0855
Japan
Saga-Ken Medical Centre Koseikan
Saga, Saga-ken 840-8571
Japan
Kagawa University Hospital
Kagawa, 761-0793
Japan
Radboud University Medical Center (Radboudumc)
Nijmegen, 6525GA
Netherlands
Non-Public Healthcare Facility Stadmedica, Ambulatory Specialist Care
Bydgoszcz, 85-391
Poland
Medrise Sp. z o.o. (LLC)
Lublin, 20-582
Poland
Jerzy Gromkowski Provincial Specialist Hospital
Wroclaw, 51-149
Poland
Asan Medical Center
Seoul, 05505
South Korea
Samsung Medical Center
Seoul, 06351
South Korea
The Catholic University of Korea, Seoul St. Mary's Hospital
Seoul, 06591
South Korea
University Hospital Virgen del Rocio (HUVR)
Seville, Andalusia 41013
Spain
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City, 807377
Taiwan
Far Eastern Memorial Hospital
New Taipei City, 220
Taiwan
Taichung Veterans General Hospital
Taichung, 407219
Taiwan
King Chulalongkorn Memorial Hospital
Bangkok, 10330
Thailand
Phramongkutklao Hospital
Bangkok, 10400
Thailand
Ramathibodi Hospital
Bangkok, 10400
Thailand
Siriraj Hospital
Bangkok, 10700
Thailand
Songklanagarind Hospital
Hat Yai, 90110
Thailand
Maharat Nakhon Ratchasima Hospital
Nakhon Ratchasima, 30000
Thailand
St Mark's Hospital
London, Middlesex HA1 3UJ
United Kingdom
Aberdeen Royal Infirmary
Aberdeen, Scotland AB25 2ZN
United Kingdom
University Hospitals Birmingham NHS Foundation Trust
Birmingham, B15 2TH
United Kingdom
Royal London Hospital
London, E1 1FR
United Kingdom
Northern Care Alliance NHS Foundation Trust, Intestinal Failure Unit
Salford, M6 8HD
United Kingdom